FDA Press Releases - EIN Presswire - Press Release Distribution Service

Published on August 11, 2022 - 17:10 GMT

At-Home COVID-19 Antigen Tests-Take Steps to Reduce Your Risk of False Negative: FDA Safety Communication

Date Issued: August 11, 2022 Perform repeat, or serial testing following a negative result on any at-home COVID-19 test, whether or not you have symptoms. The U.S. Food and Drug Administration (FDA) is advising people to perform repeat, or serial, testing …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 11, 2022 - 16:16 GMT

Do Not Use Ultraviolet (UV) Wands That Give Off Unsafe Levels of Radiation: FDA Safety Communication

Date Issued: July 20, 2022 UV wands may introduce health risks to the user or a person nearby. The U.S. Food and Drug Administration (FDA) is warning consumers about the potential risk of injury associated with the use of certain brands of ultraviolet (UV …

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Published on August 11, 2022 - 13:19 GMT

Becton Dickinson Recalls Intraosseous Needle Set Kits, Intraosseous Manual Driver Kits, and Intraosseous Powered Drivers for ...

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Name: BD Intraosseous Needle Set Kits, BD Intraosseous Manual Driver Kits, BD Intraosseous …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 9, 2022 - 16:49 GMT

Haimen Shengbang Laboratory Equipment Co. Ltd. Recalls Viral Transport Media Containers That Are Not Authorized, Cleared, or ...

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Device Use Haimen Shengbang Laboratory Equipment Co. Ltd.’s Viral Transport Media Container is a …

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Published on August 9, 2022 - 15:03 GMT

Abbott MitraClip Device: Potential for Clip Lock Malfunctions - Letter to Health Care Providers

September 8, 2022 The U.S. Food and Drug Administration (FDA) is alerting health care providers about potential clip lock malfunctions with MitraClip Clip Delivery Systems manufactured by Abbott. On September 8, 2022, Abbott issued an Urgent Medical Device …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on August 9, 2022 - 13:03 GMT

Breast Implants: Reports of Squamous Cell Carcinoma and Various Lymphomas in Capsule Around Implants: FDA Safety Communication

Date Issued: September 8, 2022 The U.S. Food and Drug Administration (FDA) is informing the public about reports of cancers, including squamous cell carcinoma (SCC) and various lymphomas, in the scar tissue (capsule) that forms around breast implants. The …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 29, 2022 - 21:17 GMT

Edgewell Personal Care Issues Voluntary Nationwide Recall of Banana Boat Hair & Scalp Sunscreen Due to the Presence of Benzene

COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

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Published on July 28, 2022 - 18:33 GMT

Covidien, LLC (Medtronic) Recalls Palindrome and Mahurkar Hemodialysis Catheters Due to Catheter Hub Defect

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Names: Palindrome and Mahurkar Hemodialysis Catheters Product Codes: MSD Model Numbers: …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 26, 2022 - 18:21 GMT

Vi-Jon, LLC Expands Voluntary Nationwide Recall of All Flavors and Lots Within Expiry of Magnesium Citrate Saline Laxative Oral ...

COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 25, 2022 - 17:19 GMT

Ultra Supplement LLC Issues Voluntary Nationwide Recall of Sustango Due to the Presence of Undeclared Tadalafil

COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 25, 2022 - 15:09 GMT

Baxter Healthcare Corporation Recalls Abacus Order Entry and Calculation Software for Risk of Medication Label Errors

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Name: Abacus Order Entry and Calculation Software Product Codes: See medical device …

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Published on July 21, 2022 - 17:10 GMT

UPDATE: Use of Renuvion/J-Plasma Device for Certain Aesthetic Procedures: FDA Safety Communication

Date Issued: July 21, 2022 The U.S. Food and Drug Administration (FDA) is providing another update on the Renuvion/J-Plasma device system by Apyx Medical about use of the device for certain aesthetic skin procedures. In March 2022, the FDA warned against …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 21, 2022 - 15:58 GMT

Voluntary Recall of Certain Over-the-Counter Products

COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement Summary Company …

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Published on July 20, 2022 - 15:12 GMT

Smiths Medical Recalls Certain Medfusion 3500 and 4000 Syringe Infusion Pumps for Software Issues That May Impact Infusion ...

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Device Use Smiths Medical Medfusion 4000 and 3500 Syringe Infusion Pumps are used to give fluids …

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Published on July 19, 2022 - 17:59 GMT

MKS Enterprise LLC Voluntary Recalls of Dose Vital VIP Vital Honey Due to Presence of Undeclared Tadalafil

COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

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Published on July 15, 2022 - 19:05 GMT

For Monkeypox Testing, Use Lesion Swab Samples to Avoid False Results: FDA Safety Communication

Date Issued: July 15, 2022 The U.S. Food and Drug Administration (FDA) is advising people to use swab samples taken directly from a lesion (rash or growth) when testing for the monkeypox virus. The FDA is not aware of clinical data supporting the use of …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 15, 2022 - 17:28 GMT

Vi-Jon, LLC Expands Voluntary Nationwide Recall of Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor Due to Microbial ...

COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 14, 2022 - 00:15 GMT

Hospira Issues a Voluntary Nationwide Recall for One Lot of Propofol Injectable Emulsion, USP (Containing Benzyl Alcohol), Due to ...

COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

Distribution channels: Healthcare & Pharmaceuticals Industry

Published on July 13, 2022 - 18:18 GMT

American Contract Systems Recalls COVID Test Kits Nonsterile and Clean Catch Urine Kits for Risk of False Results

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Names: COVID Test Kit Nonsterile and Clean Catch Urine Kit Product Codes: JSM Lot Numbers …

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Published on July 11, 2022 - 10:58 GMT

Adam’s Polishes, LLC Issues Voluntary Nationwide Recall of Hand Sanitizer Due to Potential Contamination With Methanol

COMPANY ANNOUNCEMENT When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company. Read Announcement View Product Photos …

Distribution channels: Healthcare & Pharmaceuticals Industry